NCT04210076

Brief Summary

The purpose of this study is to look at how mindfulness training may influence how the participant thinks, feels, and acts.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2022

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

December 20, 2019

Last Update Submit

August 29, 2022

Conditions

Keywords

attentional performancepsychological well-beingoperational performance

Outcome Measures

Primary Outcomes (2)

  • Change in Attentional Performance

    Attentional Performance as measured by the Sustained Attention Response Task (SART).This task uses a continuous performance paradigm involving button presses to frequently presented non-targets (numbers 1, 2, 4, 5, 6, 7, 8, and 9) but requires the participants to withhold their motor response to the infrequent target (number 3). Withholding responses only to infrequent targets encourages a pre-potent response and mind wandering. Real-time subjective experience of mind wandering during SART is assessed through experience-sampling probes randomly presented throughout the task.

    Baseline (testing session 1) to week 5 (testing session 2)

  • Change in Working Memory Performance

    Working Memory Performance as measured by the Working memory task with Affective Distracters. In this task, participants are presented with a memory array that they are to encode and hold in memory during a delay interval. During the delay, emotionally negative or neutral scene images are presented.

    Baseline (testing session 1) to week 5 (testing session 2)

Secondary Outcomes (10)

  • Change in Cohesion

    Baseline (testing session 1) to week 5 (testing session 2)

  • Change in Team Situation Monitoring

    Baseline (testing session 1) to week 5 (testing session 2)

  • Change in Workgroup Emotional Intelligence

    Baseline (testing session 1) to week 5 (testing session 2)

  • Change in Team Mindfulness

    Baseline (testing session 1) to week 5 (testing session 2)

  • Change in Mindfulness

    Baseline (testing session 1) to week 5 (testing session 2)

  • +5 more secondary outcomes

Other Outcomes (2)

  • Change in Accuracy on Cognitive and Marksmanship Drills

    Baseline (testing session 1) to week 5 (testing session 2)

  • Change in Reaction Time on Cognitive and Marksmanship Drills

    Baseline (testing session 1) to week 5 (testing session 2)

Study Arms (3)

Mindfulness-Based Attention Training for Teams (MBAT-T)

EXPERIMENTAL

Teams randomized to this group will receive 4, 2-2.5-hour sessions delivered over 4 weeks of mindfulness training and 15 minutes of daily, out-of-class mindfulness exercises, that will be delivered and tracked using a measuring mindfulness application.

Behavioral: MBAT-T

Mindfulness-Based Attention Training for Individuals (MBAT-I)

ACTIVE COMPARATOR

Individuals randomized to this group will receive 4, 2-2.5-hour sessions delivered over 4 weeks of mindfulness training and 15 minutes of daily, out-of-class mindfulness exercises, that will be delivered and tracked using a measuring mindfulness application.

Behavioral: MBAT-I

No-training

NO INTERVENTION

Teams will not engage in any mindfulness training

Interventions

MBAT-TBEHAVIORAL

The MBAT-Team program builds on the basic 4-week, 8-hour MBAT-Soldier program. In addition to the basic program, MBAT-Team includes exercises promoting the cultivation of attention and emotion regulation in the service of effective team interactions (e.g., mindful communication and listening; monitoring and attention to the activities and emotional states of others, and additional practices to promote collective mindfulness).

Mindfulness-Based Attention Training for Teams (MBAT-T)
MBAT-IBEHAVIORAL

The MBAT-Individual program is based on the basic 4-week, 8-hour MBAT-Soldier curriculum.

Mindfulness-Based Attention Training for Individuals (MBAT-I)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who are between 18 and 65 years of age
  • Individuals who are fluent English speakers
  • Individuals who are active-duty service members
  • Men and women of all races and ethnicities

You may not qualify if:

  • Individuals who have a medical or neurological condition that might interfere with performance on the task in the study (e.g., epilepsy)
  • Individuals with a history of hospitalization for psychological/mental health issues within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Related Publications (1)

  • Zanesco AP, Denkova E, Barry J, Jha AP. Mind wandering is associated with worsening attentional vigilance. J Exp Psychol Hum Percept Perform. 2024 Nov;50(11):1049-1066. doi: 10.1037/xhp0001233. Epub 2024 Aug 22.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Amishi P Jha, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 20, 2019

First Posted

December 24, 2019

Study Start

May 10, 2021

Primary Completion

April 7, 2022

Study Completion

April 12, 2022

Last Updated

September 1, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations